Injection site targeting device

ABSTRACT

An apparatus for targeting an injection site using anatomical landmarks includes a first landmark identifier, a second landmark identifier, and a targeting band. The targeting band is connected with the first landmark identifier at a first end and a second landmark identifier at a second end. At least a portion of the targeting band is linearly deformable. In another embodiment, an apparatus for targeting an injection site using anatomical landmarks on a patient includes a targeting band having a first end and a second end, at least a portion of the targeting being linearly deformable, a first landmark identifier pivotably connected to the targeting band at the first end, a second landmark identifier configured to be connected with the second end of the targeting band; and a fastener configured to secure the first and second landmark identifiers to the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/281,496, filed Jan. 21, 2016, the entire disclosureof which is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to an apparatus for targeting an injectionsite.

BACKGROUND

In medical procedures, it can be important to administer an injection orplace a treatment device at a specific site on the body. Nerve blocks,for example, can be used to manage, treat, and prevent pain. Theefficacy of a nerve block, however, depends largely upon the ability ofa health care professional to correctly identify the relevant nerve(s)and the injection site(s) associated with the relevant nerve(s), and toadminister the appropriate pharmaceuticals in close proximity to theidentified nerve without encountering structures, such as blood vessels,that are hidden beneath the skin.

Nerves are typically located using anatomical landmarks, motor-evokedpotential, or ultrasound. Each nerve-finding technique has advantagesand drawbacks. However, they all generally require a significant amountof training beyond that of a general practitioner. Further, nervefinding via motor-evoked potential or ultrasound also requires costlyequipment that requires additional training and may not be available inall clinical settings. Thus, there exists a need for a device thatfacilitates the administration of nerve blocks by eliminating the “guesswork” associated with identifying injection sites. Further, the deviceincreases the number of medical professionals, such as doctors ofdifferent specialties, and the like, that can administer nerve blocks ina clinical setting.

SUMMARY OF THE INVENTION

The present invention provides an apparatus for targeting an injectionsite using anatomical landmark guidance. In accordance with oneembodiment of the present invention, an apparatus for targeting aninjection site using anatomical landmarks includes a first landmarkidentifier, a second landmark identifier, and a targeting band connectedwith the first landmark identifier at a first end and the secondlandmark identifier at a second end. At least a portion of saidtargeting band is linearly deformable.

In accordance with another embodiment of the invention, an apparatus fortargeting an injection site using anatomical landmarks on a patientincludes a targeting band having a first end and a second end; a firstlandmark identifier pivotably connected to the targeting band at thefirst end; a second landmark identifier configured to be connected withthe second end of the targeting band; and a fastener configured tosecure the first and second landmark identifiers to the patient. Atleast a portion of the targeting is linearly deformable;

In accordance with another embodiment of the invention, an apparatus fortargeting an injection site using anatomical landmarks on a patient,includes a first landmark identifier configured to be fixed to thepatient; a pivot arm having a pivotable connection with the firstlandmark identifier; a targeting band having a first end and a secondend, at least a portion of the targeting being linearly deformable, thefirst end of the targeting band being secured at the pivotableconnection; and a second landmark identifier connected with the pivotarm.

In accordance with yet another embodiment of the invention, 22. Anapparatus for targeting an injection site using anatomical landmarks ona patient includes a targeting band having a first end and a second end;a landmark identifier having directional markers thereon; and atensioning member having a first end and a second end, the tensioningmember being pivotably connected to the landmark identifier at the firstend, the tensioning member comprising an adjustable tensioning mechanismconfigured to move between the first end and the second end, and amarker to indicate a targeted location. The first end of the targetingband is connected with the first end of the tensioning member and thesecond end of the targeting band is connected with the adjustabletensioning mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate an injection site targeting device inaccordance with the present invention.

FIGS. 2A, 2B, 2C, 2D, 2E, 2F, 2G, 2H, 2I and 2J illustrate injectionsite targeting devices in accordance with the present invention.

FIG. 3 illustrates an injection site targeting device in accordance withthe present invention.

FIG. 4 illustrates a base component of an injection site targetingdevice in accordance with the present invention.

FIG. 5 illustrates a pivot arm of an injection site targeting device inaccordance with the present invention.

FIG. 6 illustrates a cross-section of an assembled injection sitetargeting device in accordance with the present invention.

FIG. 7 illustrates an assembled injection site targeting device inaccordance with the present invention.

FIGS. 8A and 8B illustrate an injection site targeting device having alocking pivot arm, in accordance with the present invention.

FIGS. 9A and 9B illustrate an injection site targeting device having apivot arm with a track and additional support, in accordance with thepresent invention.

FIGS. 10A and 10B illustrate an injection site targeting device having apivot arm with a track, additional support, and configured to locate alandmark via manual palpation, in accordance with the present invention.

DETAILED DESCRIPTION

Reference throughout the specification to “one embodiment,” “anotherembodiment,” “an embodiment,” “some embodiments,” and so forth, meansthat a particular element (e.g., feature, structure, property, and/orcharacteristic) described in connection with the embodiment is includedin at least one embodiment described herein, and may or may not bepresent in other embodiments. In addition, it is to be understood thatthe described element(s) may be combined in any suitable manner in thevarious embodiments. Further, the term “user” herein describes anindividual or group of individuals administering the injection. Itshould also be appreciated that the features disclosed herein may becombined in various ways without departing from the scope of theinvention.

The location of underlying structures and/or tissues in the body such asnerves, tendons, muscles, vasculature, spine structures such as discsand facets, bones, joints and organs, etc. can sometimes be determinedrelative to anatomical landmarks that are identifiable via palpation orvisual inspection. In some cases, the location of these underlyingstructures is well established via, for example, scientific study. Forexample, Levin identifies the location of the preferred injection sitefor a greater occipital nerve block as being located “approximately twothirds of the distance on a line drawn from the center of the mastoid tothe external occipital protuberance.” Levin, Morris. “Nerve Blocks inthe Treatment of Headache.” Neurotherapeutics: The Journal of theAmerican Society for Experimental NeuroTherapeutics 7.1 (2010): 197-203,198. Print. In some cases, literature suggests multiple approaches tolocate a preferred injection site. Loukas, for example, suggests thatthe preferred injection site for a greater occipital nerve block is 2 cmlateral and 2 cm inferior to the greater occipital protuberance. Loukas,M., et al. “Identification of greater occipital nerve landmarks for thetreatment of occipital neuralgia.” Folia Morphologica 65.4 (2006):337-342, 347. Print. Still other publications suggest multiple injectionsites for a greater occipital nerve block, including injection sites atone third the distance between the occipital protuberance and themastoid process, at one half (the midpoint) the distance between theoccipital protuberance and the mastoid process, and at a point 1-2 cminferior to the midpoint. Voight, Crystal L. and Maurice O. Murphy.“Occipital Nerve Blocks in the Treatment of Headaches: Safety andEfficacy.” The Journal of Emergency Medicine 48.1 (2015): 115-129, 122.Print. Thus, it is essential that an injection targeting device beadaptable to a specific patient in order to permit a practitioner toadminister an injection at a site using the landmark(s) and locationmethodology that the practitioner is familiar and comfortable with.

In other cases, such as when a patient has known anatomical variations,the location of underlying structures and/or tissues may be determinedfor a specific a patient via established methods including, but notlimited to, imaging methods such as ultrasound, computed tomography(CT), and magnetic resonance imaging (MRI), nerve stimulation such asmotor evoked potential testing, and palpation and percussion techniques.In these cases, preferred injection sites can be defined for a specificpatient, for example by defining a preferred injection site relative tomultiple (two or more) anatomical landmarks, or by defining an injectionsite in terms of a distance and direction (in terms of degrees, watchface, etc.) relative to one anatomical landmark. Once preferredinjection sites are established, they can be noted in a patient'smedical records so that testing does not need to be repeated.

The present invention uses at least one anatomical landmark and known orestablished relationships relative to the at least one anatomicallandmark to provide an injection site targeting device that facilitatesconsistent, reproducible administration of injections or othertherapeutic means, such as nerve blocks, TENS, administration ofmedications, etc. across a variety of populations without requiringexpensive diagnostic equipment. Additionally, because the injection sitetargeting device essentially serves as a template for the medicalpractitioner, the training necessary to administer a nerve block usingthe injection site targeting device can be reduced compared to thetraining required to administer nerve blocks using traditionalanatomical landmark guidance techniques, imaging techniques, or nervestimulation.

Further, while the invention is described as an injection targetingdevice, it should be appreciated that the devices described herein areapplicable to any treatment or procedure that relies on reliableidentification of the location of nerves in order to be effective.Transcutaneous electrical nerve stimulation (TENS), for example,requires that electrodes be placed on the surface of the skin in closeproximity to specific nerves. Any of the devices described herein couldbe adapted to identify a site for application or to mark the skin forrepeated or later application, without departing from the scope of theinvention. Further, while a nerve block is typically administered by amedical practitioner, it should be appreciated that, in some contexts,such as TENS administration, the devices described herein areappropriate for use by a lay person, and may be used to facilitateself-administration of treatment by a patient for the administration oftherapy at home or in a non-clinical setting. The devices describedherein could also be used to place a radiofrequency probe or catheterintroducer at a specific location on the body for treatment,diagnostics, or monitoring.

FIGS. 1A and 1B illustrate an injection site targeting device 100 inaccordance with the present invention. The injection site targetingdevice 100 includes a landmark identifier 110, an adjustment mechanism115 that includes a slider 120, a targeting band 130, a marker 140, ameasurement guide 150, a directional guide 160, and a connector 170. Thelandmark identifier 110 is configured to be placed on or over ananatomical landmark that has been identified by a user. Landmarkidentifier 110 may be adapted in shape and size to suit, conform to, oraccommodate the anatomical landmark it is intended to identify. Forexample, where the identified anatomical landmark is a bony landmarkthat protrudes from the body, such as the mastoid process, the occipitalprotuberance, the medial malleolus, or the lateral malleolus, the bottomof the landmark identifier may be concave or cupped to receive a bonyprojection, may be soft and moldable to conform to the bony landmark, ormay include a partial depth hole or through hole that permits a user toidentify the position of the landmark via visual inspection orpalpation. A landmark identifier intended for use with the medialmalleolus may be larger in diameter and have a deeper cup or concavityto its shape than a landmark identifier intended for the occipitalprotuberance. Where the chosen anatomical landmark does not protrudefrom the body, for example, in the case of soft tissue landmarks such asthe edge of a facial feature such as an eyebrow, or underlying tissuethat can be identified via palpation, the landmark identifier may have aflat bottom. In still other embodiments, landmarks may be identified viaconventional imaging means and temporary, semi-permanent, or permanentmarks can be made on a patient's skin to facilitate repetitive placementof a landmark identifier via visual inspection. In some cases, at leasta portion of the landmark identifier may be inserted beneath the skin tofacilitate identification of a specific landmark via physical inspectionor palpation. Landmark identifier 110 may be constructed of anymaterial, but are preferably conducted of a material or combination ofmaterials that is unlikely to cause skin irritation. In someembodiments, it is preferable that the material or materials withstandchemical and/or heat sterilization procedures. Exemplary materialsinclude, but are not limited to, polymers, including silicone polymersand plastics, and metals and metal alloys.

Landmark identifier 110 may be held in place by a person, secured to theskin via a skin adhesive such as a silicone adhesive, secured via anelastic band, hook and loop fastener, tape, or any other fastener,frame, or combination thereof that allows for landmark identifier 110 tobe held securely against the patient's body and the anatomical landmark.It should also be appreciated that, in some embodiments, the landmarkidentifiers may be labeled or color coded to indicate the anatomicallandmark intended to be used with that specific landmark identifier. Insome embodiments, landmark identifier 110 includes a directional guide160, indicating direction via, for example, degrees (360) or in terms ofa clock face. In other embodiments, the landmark identifier may includean opening or port that allows a user to view and/or palpate ananatomical landmark to facilitate placement of the injection targetingdevice, or to view and/or palpate the anatomical landmark while theinjection site targeting device is in place on a patient. Landmarkidentifier 110 may be constructed of any material suitable to be placedagainst a patient's skin, but is preferably a material unlikely to causeskin irritation on contact. In some embodiments, it is desirable for thematerial or combination of materials to be sterilizable. Exemplarymaterials include, but are not limited to, metals such as austenitic 316stainless steel, martensitic 440 and 420 stainless steels, titaniumalloys (such as Ti6Al4V), and the like, and polymers such aspolypropylene, polytetrafluoroethylene, polyether ether ketone (PEEK),silicone, and the like.

The adjustment mechanism 115 is connected to landmark identifier 110 viaconnector 170. Connector 170 may be any fastener including, but notlimited to, a pin, screw, nut, nut/bolt combination, clamp, adhesive, orany other fastener that can secure adjustment mechanism 115 to landmarkidentifier 110 permanently, temporarily, or removably. In someembodiments, the connector may be formed integrally with the landmarkidentifier and targeting band. In some embodiments, connector 170permits the adjustment mechanism to pivot relative to the landmarkidentifier. Adjustment mechanism 115 includes slider 120, which isconfigured to move along the length of the adjustment mechanism 115. Insome embodiments, slider 120 can be secured in a specific position, forexample, by tightening connector 175. The length of adjustment mechanism115 is such that it permits the slider to move at least the distancefrom the landmark locator to the desired injection site. Preferably thetravel of the slider is greater than the distance from the landmarklocator to the desired injection site. Further, the adjustment mechanismmay be straight (flat), or curved to mimic the curvature of the part ofthe body on which it is to be used. The adjustment mechanism may beconstructed of any material with sufficient structural characteristicsto withstand manipulation and tension without deforming. In someembodiments, it is preferable that the adjustment mechanism beconstructed of sterilizable metal or polymers, or a combination thereof,as discussed with respect to the landmark identifier.

Targeting band 130 is connected to the adjustment mechanism at twopoints, and should be under increasing tension as slider 120 is movedaway from landmark identifier 110. At a first end, targeting band 130 isconnected to the adjustment mechanism 115 and the landmark identifier110 via connector 170 described above, or may be directly connected toadjustment mechanism 115. In some embodiments, the connection betweenthe landmark identifier and the targeting band is a pivotableconnection. At a second end, targeting band 130 is connected to slider120 via connector 175. Connector 175 may be a pin, screw, bolt, nut/boltcombination, clamp, adhesive, or any other appropriate fastener orfixative to temporarily, permanently, or removably connect targetingband 130 with slider 120. In some implementations, the targeting bandmay be secured at the second end by fixing the targeting band between 2portions of the slider.

Marker 140 is located on targeting band 130, and is used to indicate thepreferred injection site. The marker 140 may be located at any point onthe targeting band that will extend beyond the boundaries of thelandmark identifier under tension. In some embodiments, specific pointsare marked along the band, such as ⅓, ⅔, or both ⅓ and ⅔. In otherembodiments, multiple markers may be located on the targeting band todefine a scale. Targeting band 130 is deformable so that the position ofmarker 140 can be adjusted by moving slider 120 until marker 140 is inthe desired position, and then securing the slider to the adjustmentmechanism via, for example, a thumb screw. Adjustment mechanism 115optionally includes measurement guide 150, which may be a ruler orprovide other consistent markings to indicate position relative to theidentified anatomical landmark.

In the embodiment illustrated in FIGS. 1A and 1B, targeting band 130 maybe constructed of any material that will deform in the axial directionunder the tension created as the slider 120 is moved away from landmarkidentifier 110. Preferably, the material deforms linearly in the axialdirection over a distance of at least a few millimeters to a fewcentimeters or more, depending on the distance from the landmark to theinjection site, or the distance between the landmarks. In someembodiments, for example where the distance between landmarks isrelatively large (50 or more centimeters), it is preferable that thematerial deforms linearly in the axial direction over at least a portionof the distance between the landmarks. For example, in dealing withnerves on the head the material should deform linearly in the axialdirection when stretched 3-10 centimeters. This permits the same band tobe used on patients of different shapes and sizes, and accounts for thevariation in anatomical features that exist from person to person orpatient to patient. When landmarks are more than a few centimetersapart, it may be preferable that only a portion of the targeting bandimmediately around the injection site be constructed of a material thatdeforms linearly in the axial direction, while the surrounding sectionsof the targeting band are constructed of a material the does undergoesminimal or no deformation in the axial direction. In some embodiments,for example, where only one adjustment is necessary, such as embodimentswhere the targeting band is intended to be disposable or for single use,plastic deformation of targeting band 130 is acceptable. A non-limitingexample of a material that would undergo plastic deformation in thiscontext is polyvinyl chloride (plastic wrap). In other embodiments, forexample, where repeated adjustment may be necessary, or where thetargeting band is to be reused, elastic deformation is preferable. Anon-limiting example of a material that deforms linearly in this contextis high purity silicone rubber.

Marker 140 indicates the desired injection site and may be a mark on thetargeting band, a through hole, a through hole covered by a thin film, ascored mark or partial-depth hole configured to guide a needle and/orlimit the depth to which a needle can be inserted, or a tapered orfunnel-shaped opening configured to guide a needle on the superior orinferior surface, direct the trajectory of a need, and/or limit thedepth to which a needle can be inserted. In some embodiments, marker 140may be formed continuously as part of targeting band 130, for example,when targeting band 130 is formed via a molding process using highpurity silicone rubber. In other embodiments, marker 140 may be formedof a different material, such as metal or plastic, that is inserted intoan opening in targeting band 130 or fixed in targeting band 130 duringthe manufacturing process, forming an eyelet or tunnel in the targetingband. In some embodiments, a marker may be added by a user aftermanufacture, for example by piercing the targeting band at anappropriate point and inserting a metal or plastic marker, or by makinga mark on the targeting band before use, for example, with a permanentmarker.

The embodiment illustrated in FIGS. 1A and 1B is particularly useful incases such as that described by Loukas, where the preferred injectionsite for a greater occipital nerve block is indicated as being 2 cmmedial and 2 cm inferior to the occipital protuberance. Using basicgeometry, the preferred injection site is approximately 2.83 cm from theoccipital protuberance at about 270 degrees. In order to use theinjection targeting device of FIGS. 1A and B, one would place thelandmark identifier on a patient's occipital protuberance, orienting thedirection guide in the same manner as a compass, adjust and fix theslider so that the marker is located 2.83 cm from the landmarkidentifier, and pivot the adjustment mechanism (and targeting band) sothat the marker is located at 270 degrees using the direction guide.

FIGS. 2A and 2B illustrates an injection site targeting device inaccordance with the present invention. The injection site targetingdevice includes two landmark identifiers 210, 220, a targeting band 230,connectors 270 and 275, and a marker 240 to identify a preferredinjection site. Each landmark identifier 210, 220 is configured to beplaced on an anatomical landmark that has been identified by a medicalprofessional or by a layperson. Landmark identifiers 210 and 220 may beadapted in shape and size to suit the landmark they are intended toidentify without departing from the scope of the invention. For example,where the identified anatomical landmark is a bony landmark thatprotrudes from the body, such as the mastoid process, the occipitalprotuberance, the medial malleolus, or the lateral malleolus, the bottomof the landmark identifier may be concave or cupped to receive a bonyprojection, may be soft and moldable to conform to the bony landmark, ormay include a partial depth hole or through hole to permit visualinspection and/or palpation by a user. A landmark identifier intendedfor use with the medial malleolus may be larger than a landmarkidentifier intended for the occipital protuberance. Where the chosenanatomical landmark does not protrude from the body, for example, in thecase of soft tissue landmarks such as the edge of a facial feature suchas an eyebrow, the landmark identifier may have a flat bottom.

Landmark identifiers 210 and 220 may be constructed of any material, butare preferably conducted of a material or combination of materials thatis unlikely to cause skin irritation. In some embodiments, it ispreferable that the material(s) can be sterilized. Exemplary types ofmaterials include, but are not limited to, polymers, including plasticsand silicone, and metals and metal alloys. Exemplary materials include,but are not limited to, metals such as austenitic 316 stainless steel,martensitic 440 and 420 stainless steels, titanium alloys (such asTi6Al4V), and the like, silicone, and plastics such as polypropylene,polytetrafluoroethylene, polyether ether ketone (PEEK), and the like.Landmark identifiers 210 and 220 may be held in place by a person,secured via a skin adhesive such as a silicone adhesive, secured via anelastic band, hook and loop fastener, tape, deformable materials, or anyother fastener, frame, or combination thereof that allows for landmarkidentifiers 210 and 220 to be held securely against the patient's skinand, in turn, the identified landmark. It should also be appreciatedthat, in some embodiments, the landmark identifiers may be labeled orcolor coded to indicate the anatomical landmark intended to be used withthat specific landmark identifier.

Targeting band 230 is connected to the landmark identifiers 210, 220 viaconnectors 270, 275. Connectors include, but are not limited to, pins,adhesives, clamps, screws, nuts, nuts and bolts, and the like. In someembodiments, the landmark identifiers may be formed integrally with thetargeting band. The connection between targeting band 230 and thelandmark identifiers may be permanent or removable and may bepivotable/rotatable or fixed. Targeting band 230 may be constructed ofany material that deforms linearly under slight tension. In someembodiments, the targeting band may be constructed of a material thatundergoes linear elastic deformation under slight tension. Preferably,targeting band 230 is constructed of a material that undergoes lineardeformation under slight tension. In some embodiments, targeting band230 may undergo linear elastic deformation under slight tension.

In some embodiments, the targeting band is constructed of a materialthat has a type A durometer hardness of 50-80, a tensile strength of1000-1500 psi, elongation of 300%-700%, tear strength of 100-400 ppi,and specific gravity of 1-1.4. Exemplary materials include, but are notlimited to, medical grade silicone including high purity siliconerubber, polyurethane, urethane copolymers, and foamed silicone. In someembodiments, it is preferable that the targeting band be constructed ofan auxetic material, which has a negative Poisson's ratio in addition tothe aforementioned materials characteristics, meaning that the materialbecomes slightly thicker and, in some cases, more rigid when stretched.In some embodiments, it is preferable, that the targeting band beconstructed of an elastomer (such as polyurethane or silicone materials)that has a durometer hardness of 50-70 Shore A, a tensile strength of1100-1300 psi, elongation of 300-500%, tear strength of 200-300 ppi. Thetargeting band is preferably slightly shorter than the distance betweenthe two landmarks (in average populations) so that, when properlypositioned, the targeting band is under slight tension. In still otherembodiments, the targeting band may be trimmed to a desired length by auser.

Marker 240 marks the preferred injection site on the targeting band,based on the relative relationship between the landmarks. The locationof marker 240 is determined based on the location of the desiredinjection site (nerve) relative to two anatomical landmarks, for example40% of the distance between landmark A and landmark B. Thus, thelocation of the marker 240 may be varied based on the desired injectionsite and its position relative to anatomical landmarks. In someembodiments, the marker is a dot or other symbol printed on thetargeting band. In other embodiments, the marker is a through hole orpartial-depth hole that is covered by a thin membrane or film that isconfigured to be punctured by a needle, for example to indicate that thetargeting band is “new.” In still other embodiments, marker 240 is ashaped opening that serves as a needle guide and may be configured tolimit the depth of insertion of the needle by forming a physicalbarrier, and/or may be configured to guide the needle at a specific pathor trajectory. As described with respect to the embodiment illustratedin FIGS. 1A and 1B, the marker may be formed of the same material as thetargeting band via, for example, molding, or may be formed of anothermaterial entirely and inserted in the targeting band during or aftermanufacture. In still other embodiments, the marker may be a scaleprinted on the targeting band or series of holes in the targeting bandat defined intervals. By providing relative measurements rather than aspecific mark, a medical professional can use his or her knowledge tochoose an appropriate injection site using the scale. Because thetargeting band undergoes linear deformation under slight tension, marker240 will move as the targeting band stretches. Thus, a marker located40% between the two landmark identifiers will continue to remain at 40%as the landmark locators are moved apart and the targeting band isstretched. This linear deformation allows the injection targeting deviceto be used on patients of varying shapes and sizes with consistent andreproducible results.

FIGS. 2C and 2D illustrate exemplary embodiments of injection targetingdevices where the landmark identifiers 210 and 220 are formed integrallywith the targeting band 230, and designed to be held in place using anadhesive and/or pressure applied by a practitioner, provider, thepatient, or a third party. In FIG. 2C, landmark identifiers 210 and 220include through holes configured to allow a user to inspect thepatient's body, for example via visual inspection or manual palpation,in order to facilitate identification of the desired landmarks. FIG. 2Dillustrates an embodiment similar to that illustrated in FIG. 2C, butincludes integrated personal protective personal protective equipment(PPE) 225, in this case a glove, is connected with the landmarkidentifiers 210, 220 at 2 points. While the illustrated connectionpoints to the landmark identifier is illustrated at the thumb andforefinger of the glove, it should be appreciated that the PPE may beconnected at any points that will allow for the medical practitioner toproperly locate the landmark identifiers while placing tension on thetargeting band. The connection points may vary, for example, with thesize of the glove. A glove designed for a larger hand may connect at thethumb and index finger, while a glove designed for a smaller hand mayconnect at the thumb and middle finger.

FIGS. 2E and 2F illustrate two different views of an exemplaryembodiment of an injection targeting device configured to conform to thebody of a patient. In the embodiment of FIGS. 2E and 2F, targeting band230 has an inverted v-shape. Targeting band 230 includes multiplemarkers 240. Landmark identifiers 210 and 220 include through holes, andare formed integrally with targeting band 230. Targeting band 230 isattached to or embedded in a fastener 270, which is an elastic materialthat stretches and conforms to a patient's body to secure the landmarkidentifiers and, thus, markers in place on a patient. In someembodiments, the elastic material may be secured in place via hook andloop fasteners, snaps, buckles, or the like. In other embodiments, theelastic material may be self adhering material, such as 3M™ Coban™, thatis secured by overlapping the material once it is wrapped around thebody. Preferably, if the material is to be wrapped around the face or ajoint, openings exist in the material to accommodate facial features,ears, and other anatomical features. The embodiment illustrated in FIGS.2E and 2F also permits for simultaneous identification of multipleinjection sites in the case where bilateral injection sites exist on thebody.

FIGS. 2G and 2H illustrate an exemplary implementation in which a frameis used to fix the targeting band to a patient. Specifically, thefastener 270 in this case is an adjustable frame that fits behind thehead and over and around the ears of a patient, similar to “behind thehead headphone” designs. Once the occipital protuberance 220 is located,the rear band of the frame can be adjusted to fit the head of thepatient, for example via spring tension, sliding, or ratchetingmechanisms, or the like. The ends of the rear band are semi-rigid andare configured to be bent around the ears of the patient, in the reversefashion of conventional eyeglasses. For example, the rear band of theframe extends over the top of a patient's ears, and down along the frontof the ear, and each end of the band is bendable around the bottom ofthe patient's ears and back towards the mastoid process. The semi-rigid,bendable/deformable ends of the band also serve as landmark identifiers210. Targeting band 230 is connected to the fastener 270 via a pivotingconnection 255, which allows the targeting band to be secured tolandmark identifier 210 on either side of the patient's head via afastener, adhesive, or the like. Once targeting band 230 is secured tothe second landmark identifier 210—identifying the mastoid process oneither side of the patient—the targeting band 230 is under tension andthe markers 240 can be used to identify injection sites. The rear bandcan be formed of a polymer, plastic, or metal. The semi-rigid(deformable) portions should retain the new shape once positioned,accordingly it is preferable that the semi-rigid portions be constructedof a deformable metal interior (wire) covered by foam, fabric, or othersoft material that is unlikely to cause skin irritation, for patientcomfort.

FIGS. 2I and 2J illustrate an exemplary implementation in which acombination of a frame and band used to fix the targeting band to apatient. In this embodiment, the fastener 250 is a an adjustable framethat fits behind the head and sits on top of a patient's ears. A band270, such as an elastic band or hook and loop band, is configured towrap around the front of a patient's head to further secure the frame.Once the occipital protuberance 220 is located, the rear band of theframe can be adjusted to fit the head of the patient, for example viaspring tension, sliding, or ratcheting mechanisms, or the like. The endsof the rear band are semi-rigid and are configured to be bent along theback of a patient's ears, similar to the earpieces of conventionaleyeglasses. The semirigid, bendable/deformable ends of the band alsoserve as landmark identifiers 210. Targeting band 230 is connected tothe fastener 250 via a pivoting connection 255, which allows thetargeting band to be secured to landmark identifier 210 on either sideof the patient's head via a fastener, adhesive, or the like. Oncetargeting band 230 is secured to the second landmark identifier210—identifying the mastoid process on either side of the patient—thetargeting band 230 is under tension and the markers 240 can be used toidentify injection sites. The rear band can be formed of a polymer,plastic, or metal. The semi-rigid (deformable) portions should retainthe new shape once positioned, accordingly it is preferable that thesemi-rigid portions be constructed of a deformable metal interior (wire)covered by foam or other soft material that is unlikely to cause skinirritation, for patient comfort.

To use the injection targeting device of FIGS. 2A through 2J, a medicalprofessional locates the first anatomical landmark and fixes the firstlandmark identifier in place. The medical professional then fixes thesecond landmark identifier in place, using a fastening mechanism, andplacing slight tension on the targeting band. The marker should then bein position to identify the preferred injection site so that a nerveblock can be administered because the targeting band stretches linearly.

FIG. 3 illustrates an injection site targeting device in accordance withthe present invention. In the embodiment illustrated in FIG. 3, thefirst landmark identifier 310 is configured to be anchored to a patientby elastic band 360. It should be appreciated, however, that any of thefixation mechanisms described herein may be used to anchor the injectionsite targeting device including, but not limited to, hook and loopfasteners, adhesive, a string, a headband, etc. The first landmarkidentifier 310 and the second landmark identifier 320 are connected viaa ratcheting tensioning member 350, and targeting band 330 is disposedwithin ratcheting tensioning member 350 such that the ratchetingtensioning member tensions the targeting band 330 as the position of thesecond landmark identifier 320 is adjusted. The tensioning mechanism maybe constructed of materials such as those described with respect to theadjustment mechanism of FIGS. 1A and 1B, and the targeting band ispreferably constructed of a material as described with respect to theembodiment illustrated in FIGS. 2A and 2B. While FIG. 3 illustrates aratchet mechanism to adjust the length of the tensioning member, itshould be appreciated that a variety of mechanical mechanisms could beused including, but not limited to, a cam mechanism, a slide, a threadeddevice, or the like could be used to adjust the tensioning member.

FIG. 4 illustrates a base component of an injection targeting devicedesigned for the abortive and prophylactic treatment of headaches usingoccipital nerve blocks, which provides a pivotable connection to a pivotarm of an injection targeting device in accordance with the presentinvention. However, it should be appreciated that the design can beadapted to work with any injection site that can be defined by itsposition relative to an anatomical landmark. In the embodimentillustrated in FIG. 4, attachment points 460 include loops through whichan elastic band, a ribbon or string, a cam or ratcheting strap, or alength of hook and loop fastener can be threaded to affix the device toa patient. It should be appreciated that the base component can be heldin place using any of the means described herein. Landmark locator 410is located at the bottom of the base component, and includes a concavityor depression to accommodate a patient's occipital protuberance.Threaded rod 470 protrudes from the base component through a slot 480 inrotary mount 420, and is pivotably connected to the base component, sothat threaded rod 470 pivots in slot 480 in rotary mount 420. Pivot orrotary mount 420 allows for rotation of the threaded rod 470, so thatthreaded rod can pivot in the desired direction or orientation toaccommodate curvature of a body part such as the skull. In someembodiments, it is preferable that the base component is comprised ofmetal or another material capable of withstanding sterilization, asdescribed with respect to the embodiments in FIGS. 1A, 1B, 2A, and 2B.

FIG. 5 illustrates a pivot arm including a tensioning member and atargeting band in accordance with the present invention, for use withthe base component illustrated in FIG. 4. Tensioning member 415 is amechanical slide that is curved to accommodate the shape of a humanhead. As illustrated in FIG. 5, targeting band 430 is sandwiched betweenthe tensioning member 415 and landmark locator 420 at first end.However, various configurations for the tensioning member are possible.For example, the tensioning member may extend from the side of thedevice, to facilitate manipulation of the tensioning member and minimizeinterference with the targeting band and injection site location. Itshould also be appreciated that the targeting band may be attached tothe tensioning member using any conventional attachment mechanism.Targeting band 430 has a second attachment point 435 at its second end,which is configured to receive threaded pivoting rod 470. When theinjection targeting device is completely assembled, threaded pivotingrod 470 extends through second attachment point 435 in targeting band430 and through sliding retaining bracket 460. The basecomponent/targeting band/sliding retaining bracket assembly is securedtogether via thumb nut 490. Sliding retaining bracket 460 slides withinthe slot of tensioning member 415 when tension applied via thumb nut 490permits for adjustment. When sliding retaining bracket 460 is in thedesired position, which preferably places landmark locators 410 and 420over the desired anatomical landmarks, thumb nut 490 can be tightened tofix the injection targeting device in the appropriate position toadminister an injection. It should be appreciated that the materials forthe base member, tensioning member, landmark identifiers, and thetargeting band have been described with respect to the embodimentsillustrated in FIGS. 2A, 2B, and 3.

Landmark locator 420 has a concave bottom configured to receive themastoid process. Once landmark locator 420 is placed, thumb nut 490 istightened to fix the retaining bracket 460 in position, placing tensionon targeting band 430, which deforms linearly, as described with respectto the embodiment illustrated in FIGS. 2A and 2B, so that the markerremains in the same position relative to the landmark locators. Thefully assembled injection targeting device is illustrated in FIGS. 6 and7. Markers 440 and 450 identify the target injection sites for thelesser occipital nerve and greater occipital nerve, respectively. Oneknown set of guidelines for locating an injection site for greateroccipital nerve blocks and lesser occipital nerve blocks provides thatthe lesser occipital nerve is located one third the distance starting atthe mastoid process and traveling in a line to the occipitalprotuberance, and the greater occipital nerve is located one third thedistance starting at the occipital protuberance and traveling in line tothe mastoid process. Thus, in the case of the greater occipital nerveand lesser occipital nerve, two injection sites can be targetedsimultaneously with one device.

It should appreciated that the marker may be placed at any specified ordesired point on the targeting band, and that multiple markers may beplaced on the same band. In a non-limiting example, one occipital nerveblock administration guideline suggests that a preferred injection islocated at a distance of 20% to 23% from the occipital protuberance whentraveling in line to the mastoid process. Thus, if this is a user'spreferred guideline, a marker may be placed anywhere from 20% to 23% ofthe length of the targeting band, for example, a marker may be placed at22% for this use.

FIGS. 8A and 8B illustrate an injection site targeting device having alocking pivot arm, in accordance with the present invention including alinearly deformable targeting band. In the embodiment of FIGS. 8A and8B, landmark identifier 820 is fastened to a landmark (in this case, theoccipital protuberance) on a patient via a headband 850 constructed ofelastic material, hook and loop fastener, or headband design thatpermits for adjustability in sizing. The pivot arm 880 is attached tolandmark identifier 820 via a pivotable connection 855. Pivotableconnections include all pivot joints, including friction lock pivotjoints, tension pivot joints, sliding pivot joints, combinationsthereof, and the like. In the embodiment illustrated in FIGS. 8A and 8B,the connection is also slidable, permitting manipulation of the pivotarm 880 by a user so that landmark identifier 810 can be placed ondesired landmark (in this case the mastoid process). Any of a variety ofmechanical locking mechanisms, such as a push button locking/unlockingmechanism, adjustable tension, or combinations thereof, may be used topermit manipulation of the pivot arm and/or lock the pivot arm in place.Targeting band 830, including markers 840, is fixed to the pivot arm atlandmark identifier 810, and at pivotable connection 855. Thus,targeting band 830 deforms as pivot arm 880 is manipulated.

FIGS. 9A and 9B illustrate an injection site targeting device having apivot arm with a track and additional support, in accordance with thepresent invention invention including a linearly deformable targetingband. In the embodiment of FIGS. 9A and 9B, landmark identifier 920 isfastened to a landmark (in this case, the occipital protuberance) on apatient via a headband 950 constructed of elastic material, hook andloop fastener, or headband design that permits for adjustability insizing. The pivot arm 980 is attached to landmark identifier 920 via apivotable connection 955. Pivotable connections include all pivotjoints, including friction lock pivot joints, tension pivot joints,sliding pivot joints, combinations thereof, and the like. In theembodiment illustrated in FIGS. 9A and 9B, the connection is alsoslidable, permitting manipulation of the pivot arm 980 by a user so thatlandmark identifier 910 can be placed on desired landmark (in this casethe mastoid process). Any of a variety of mechanical locking mechanisms,such as a push button locking/unlocking mechanism, adjustable tension,or combinations thereof, may be used to permit manipulation of the pivotarm and/or lock the pivot arm in place. The embodiment illustrated inFIGS. 9A and 9B also includes a support 985, which is designed toprovide additional support and stability for pivot arm 980 during theinjection process.

In the embodiment of FIGS. 9A and 9B, targeting band 930, includingmarkers 940, is fixed to the pivot arm at landmark identifier 810, andat pivotable connection 855. Markers 940 include needle guides oreyelets, which provide structure for the markers. Pivot arm 980 includesa track 990, which slidably guide the needle guides as targeting band930 deforms linearly.

FIGS. 10A and 10B illustrate an injection site targeting device havinglinearly deformable targeting band and a pivot arm with a track,additional support, and configured to locate a landmark via manualpalpation, in accordance with the present invention. In the embodimentof FIGS. 10A and 10B, landmark identifier 1020 is fastened to a landmark(in this case, the occipital protuberance) on a patient via a headband1050 constructed of elastic material, hook and loop fastener, orheadband design that permits for adjustability in sizing. The pivot arm1080 is attached to landmark identifier 1020 via a pivotable connection1055. Pivotable connections include all pivot joints, including frictionlock pivot joints, tension pivot joints, sliding pivot joints,combinations thereof, and the like. In the embodiment of FIGS. 10A and10B, landmark identifier 1010 is a through hole in targeting band 1030.In some embodiments, the through hole may be reinforced with a rigidmaterial such as a metal or plastic insert. Any of a variety ofmechanical locking mechanisms, such as a push button locking/unlockingmechanism, adjustable tension, or combinations thereof, may be used topermit manipulation of the pivot arm and/or lock the pivot arm in place.Targeting band 1030, including markers 1040, is configured to slide orbe stretched along a slot or track 1090 in pivot arm 1080. In someembodiments, the position of targeting band 1030 and markers 1040 issecured by the user placing his or her finger on the landmark throughthe hole 1010. In other embodiments, targeting band 1030 slides along atrack that includes a fixation mechanism that squeezes or clamps theband in place once the second landmark is located, fixing the targetingband in place and maintain tension on the targeting band. In still otherembodiments, the position of the targeting band in the track may bemanipulated via a ratchet mechanism. Support 1085 at the free end of thepivot arm provides support for the injection targeting device when inuse.

It should be understood that, while examples are provided for targetingthe greater and lesser occipital nerves, the targeting device disclosedherein can be applied to consistently target any location on the bodythat has a location that can be described relative to one landmark witha distance and relative direction, or that can be described relative totwo landmarks, without departing from the scope of the invention. Allfigures included herein should be interpreted as illustrative ofnon-limiting, exemplary embodiments, and not in a limiting sense.

What is claimed is:
 1. An apparatus for targeting an injection siteusing anatomical landmarks, comprising: a first landmark identifier; asecond landmark identifier; and a targeting band connected with thefirst landmark identifier at a first end and the second landmarkidentifier at a second end, wherein at least a portion of said targetingband is linearly deformable in an axial direction under slight tension,the targeting band further comprising a marker identifying the injectionsite on the targeting band, wherein the marker comprises a needle guide.2. An apparatus according to claim 1, wherein the first landmarkidentifier, second landmark identifier, and targeting band are formedintegrally.
 3. An apparatus according to claim 1, further comprising atensioning member connected to the first and second landmark identifiersand configured to maintain tension on the targeting band after the firstand second landmark identifiers are positioned on landmarks.
 4. Anapparatus according to claim 3, wherein the tensioning member ispivotably connected to one of the first and second landmark identifiers.5. An apparatus according to claim 3, wherein the tensioning member is amechanical slide.
 6. An apparatus according to claim 3, furthercomprising a fastener connected with one of the first and secondlandmark identifiers, said fastener being configured to fix the positionof the apparatus on a head of the patient.
 7. An apparatus according toclaim 6 wherein the first landmark identifier is connected with thefastener, and the tensioning member extends between the second landmarkidentifier and the fastener.
 8. An apparatus according to claim 7,wherein the fastener is a headband.
 9. An apparatus according to claim1, wherein the targeting band includes at least a portion that isnon-deformable under small amounts of tension.
 10. An apparatusaccording to claim 1, wherein the marker is through hole in thenon-deformable portion of the targeting band.
 11. An apparatus accordingto claim 1, wherein the marker is on the linearly deformable portion ofthe targeting band.
 12. An apparatus according to claim 1, wherein thetargeting band is constructed of a material that has a negativePoisson's ratio.
 13. An apparatus for targeting an injection site usinganatomical landmarks on a patient, comprising: a targeting band having afirst end and a second end, at least a portion of the targeting beinglinearly deformable, the targeting band comprising a marker identifyingthe injection site; a first landmark identifier pivotably connected tothe targeting band at the first end; a second landmark identifierconfigured to be connected with the second end of the targeting band;and a fastener configured to secure the first and second landmarkidentifiers to the patient.
 14. An apparatus according to claim 13,wherein the targeting band includes at least a portion that isnon-deformable under small amounts of tension.
 15. An apparatusaccording to claim 13, wherein the marker is on the linearly deformableportion of the targeting band.
 16. An apparatus according to claim 13,wherein the marker comprises a needle guide.
 17. An apparatus accordingto claim 13, wherein at least a portion of the targeting band isconstructed of a material that has a negative Poisson's ratio.
 18. Anapparatus according to claim 13, wherein the fastener is a headband. 19.An apparatus for targeting an injection site using anatomical landmarks,comprising: a first landmark identifier; a second landmark identifier;and a targeting band connected with the first landmark identifier at afirst end and the second landmark identifier at a second end, wherein atleast a portion of said targeting band is linearly deformable in anaxial direction under slight tension, the targeting band furthercomprising a marker identifying the injection site on the targetingband; a fastener connected with the first landmark identifier, saidfastener being configured to fix the position of the apparatus on a headof the patient; a tensioning member connected to the second landmarkidentifier and configured to maintain tension on the targeting bandafter the first and second landmark identifiers are positioned onlandmarks, wherein the tensioning member extends between the secondlandmark identifier and the fastener.
 20. An apparatus according toclaim 19, wherein the fastener is a headband.